Medline Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Convenience kits (Model SUT15830A, Lot 24IBR642) are recalled due to potential weak or open seals on breather pouches that could compromise sterility. The recall affects units distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—weak breather pouch seals—presents a theoretical risk of sterility compromise in medical kits, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling select Medline Convenience kits (NAIL PACK, Model SUT15830A) used for various medical procedures. The recall was initiated due to a potential for open or weak seals on the breather pouches used to package these sterile convenience kits.
The breather pouch defect could compromise the sterility of the packaged kits. Affected units bear the UDI-DI 10653160996750 (individual units) and 40653160996751 (cases), with Lot Number 24IBR642 specifically identified.
The affected convenience kits were distributed worldwide, including throughout the United States, Canada, Mexico, Panama, and the Virgin Islands. This is an FDA Class II recall.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Number: SUT15830A;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure kits
- Hazard
- weak-seals
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1) SUT15830A
- UDI-DI: 10653160996750(each)
- 40653160996751(case)
- Lot Number: 24IBR642
Distribution
Distributed nationwide across the United States.
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